07:49 AM EDT, 03/24/2026 (MT Newswires) -- Rezolute ( RZLT ) said Tuesday the US Food and Drug Administration has encouraged the company to submit comprehensive data from its phase 3 study of ersodetug to support next steps for its congenital hyperinsulinism program.

In a meeting with the FDA last week, Rezolute ( RZLT ) said the regulator acknowledged challenges in the trial, including varied behavioral factors affecting outcomes, but reiterated the need for adequate and well-controlled studies to support efficacy for approval.

Rezolute ( RZLT ) said the phase 3 study previously showed reductions in hypoglycemia events but did not meet its primary endpoint, as results were not statistically significant compared with placebo.

The company said it expects to provide an update on the program in H2 after submitting study reports and analysis datasets for the regulator's independent evaluation.